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Obstructive Sleep Apnea Therapy by Stimulation of the Hypoglossal Nerve (AIRSTIM)

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ClinicalTrials.gov Identifier: NCT03844295
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : November 17, 2020
Sponsor:
Collaborator:
Inspire Medical Systems, Inc.
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

Continuous positive airway pressure (CPAP) is the gold standard to normalize breathing during sleep in patients with obstructive sleep apnea syndrom (OSA). Many patients will not tolerate or will not accept CPAP. Implanted nerve stimulation is a novel therapy for OSA patients that restores the upper airway potency using unilateral XII nerve electric stimulation.

The principal objective of this study is short-term efficacy of a new treatment for OSA on blood pressure variability during sleep.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Device: Activated Inspire® Upper Airway Stimulation System Device: Inactivated Inspire® Upper Airway Stimulation System Not Applicable

Detailed Description:

Obstructive sleep apnea (OSA) syndrome had become over the last decade a serious health concern due to its high prevalence which raise 10% of the general population.

It is characterized by recurrent episodes of airflow obstruction in the upper airway (UA) consequence of passive collapse of the UA, particularly at the tongue level. These collapses induce recurrent asphyxia that results in oxygen desaturations with persistant and crescendo respiratory efforts inducing arousals from sleep.

Indeed, despite its large efficacy some of the patients will never accept continuous positive airway pressure treatment or will not tolerate. To this extent, alternative treatement has been developed: implanted hypoglossal stimulation. This treatment has been developed by Inspire Medical Device. The Inspire® system is intended to prevent base-of-tongue obstruction as well as specific soft palate obstructions by stimulating the hypoglossal nerve synchronous with respiration.

A selection processus will be applied in order to identify the patients that will be good responders to the hypoglossal stimulation.

The main criterion of selection is based on Drug Induced Sleep Endoscopy(DISE) that will be performed by a trained endoscopist dedicated to this study.

This sleep endoscopy allows to visualize during induced sleep the shape of the UA and the type of collapsus. Indeed an antero-posterior collapsus is related to a good response to hypoglossal nerve stimulation while complete concentric obstruction at velopharyngeal is a predictor of poor response.

In this pilot study, the investigators evaluate as a primary outcome the delta range of blood pressure during sleep but also other cardiovascular indexes targeting blood pressure and heart rate variability as secondary outcomes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Monocentric, prospective, controlled, patient single-blind study
Masking: Single (Participant)
Masking Description: Only patient will be blind. He doesn't know if INSPIRE therapy was activated or not
Primary Purpose: Treatment
Official Title: Upper AIRway Implanted Nerve STIMulation Therapy: A Breakthrough in Obstructive Sleep Apnea Therapy
Actual Study Start Date : March 21, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Activated Inspire® Upper Airway Stimulation System
INSPIRE® device will be active a month
Device: Activated Inspire® Upper Airway Stimulation System
At first, INSPIRE® device will be active a month

Placebo Comparator: Inactivated Inspire® Upper Airway Stimulation System
After a period 15 days of "wash-out" the INSPIRE® device will be inactivated for a second period of one month.
Device: Inactivated Inspire® Upper Airway Stimulation System
After 15 days "wash-out" INSPIRE® device will be inactivated for a second period of one month.




Primary Outcome Measures :
  1. Short-term efficacy of a new treatment for OSA on systolic blood pressure variability during sleep [ Time Frame: one month treatment active versus non active treatment ]
    Change in the difference between delta nocturnal systolic blood pressure (difference between maximum and minimal nocturnal systolic blood pressure ; nocturnal period is defined from 10 pm to 7am).


Secondary Outcome Measures :
  1. Short-term efficacy of a new treatment for OSA on mean-24h, daytime and nighttime blood pressure [ Time Frame: one month treatment active versus non active treatment ]
    Ambulatory 24h arterial blood pressure

  2. Clinical efficacy of this new treatment on OSA by Epworth sleepiness scale score [ Time Frame: one month treatment active versus non active treatment ]
    It's a self-administered questionnaire with 8 questions. Patients are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person has daytime sleepiness.

  3. Clinical efficacy of this new treatment on Apnea-Hypopnea Index measured by polysomnography [ Time Frame: one month treatment active versus non active treatment ]
    Apnea-Hypopnea Index expressed in number per hour

  4. Change in sympatho-vagal balance based on heart rate variability analysis [ Time Frame: one month treatment active versus non active treatment ]
    ECG polysomnography

  5. Self-reported changes in sleep and quality of life by SF-36 score [ Time Frame: one month treatment active versus non active treatment ]
    The SF-36 is a 36-item scale constructed to survey health status and quality of life (Ware & Sherbourne, 1992), assessing eight health concepts: limitations in Quality of life physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems); bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. The standard form of the instruments asks for participants to reply to questions according to how they have felt over the previous week. The items use Likert-type scales, some with 5 or 6 points and others with 2 or 3 points. The SF-36 has been widely used and has excellent psychometrics.

  6. Sleep latency assessed during a Maintenance of Wakefulness Test [ Time Frame: one month treatment active versus non active treatment ]
    Mean sleep latency from the 4 sessions of the Maintenance of Wakefulness Test

  7. Nocturnal pulse pressure assessed by Continuous Non-invasive Arterial Pressure monitoring [ Time Frame: one month treatment active versus non active treatment ]
    Pulse pressure variability indexe DeltaBP in mmHg.

  8. Short-term efficacy of a new treatment for OSA on diastolic blood pressure variability during sleep [ Time Frame: one month treatment active versus non active treatment ]
    Change in the difference between delta nocturnal systolic blood pressure (difference between maximum and minimal nocturnal systolic blood pressure ; nocturnal period is defined from 10 pm to 7am).

  9. Clinical efficacy of this new treatment on OSA by Pichot weakness scale score [ Time Frame: one month treatment active versus non active treatment ]
    It's a self-administered questionnaire with 8 questions. Patients are asked to rate, on a 5-point scale (0-4), their usual feeling of tiredness or weakness while engaged in eight different activities. The PWS score (the sum of 8 item scores, 0-4) can range from 0 to 32. The higher the PWS score, the higher that person has weakness.

  10. Clinical efficacy of this new treatment on nocturia [ Time Frame: one month treatment active versus non active treatment ]
    Assessment of nocturia number by nigt

  11. Clinical efficacy of this new treatment on morning asthenia [ Time Frame: one month treatment active versus non active treatment ]
    Patients are asked to assess, on a visual analogic scale morning asthenia. The items use a visual analogic scales from 0 to 10 points.

  12. Clinical efficacy of this new treatment on morning headache [ Time Frame: one month treatment active versus non active treatment ]
    Patients are asked to assess, on a visual analogic scale morning headache. The items use a visual analogic scales from 0 to 10 points.

  13. Clinical efficacy of this new treatment on snoring [ Time Frame: one month treatment active versus non active treatment ]
    Patients are asked to assess, on a visual analogic scale snoring. The items use a visual analogic scales from 0 to 10 points.

  14. Self-reported changes in sleep and quality of life by FOSQ score [ Time Frame: one month treatment active versus non active treatment ]
    This is a disease specific quality of life questionnaire to determine functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment. The 5 domains that the FOSQ measures are as follows: Activity level, vigilance, intimacy and sexual relationships, general productivity, social outcome, rate the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty).

  15. Clinical efficacy of this new treatment on oxygen desaturation index measured by polysomnography [ Time Frame: one month treatment active versus non active treatment ]
    Oxygen desaturation index expressed in number

  16. Clinical efficacy of this new treatment on sleep efficacy measured by polysomnography [ Time Frame: one month treatment active versus non active treatment ]
    Sleep efficacy expressed by ratio of total sleep time on total sleep period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient aged 18 to 80 years old
  • Patient with moderate to severe OSA based on an established diagnosis of OSA (15≤AHI<65) by polysomnography or respiratory polygraphy not older thant three years.
  • Patient with moderate to severe OSA naïve of treatment or with difficulty accepting or adhering to CPAP treatment.
  • Willing and capable to have stimulation hardware permanently implanted, and to use the patient programmer to activate the stimulation
  • Willing and capable to return for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
  • Willing and capable of providing written informed consent.

Exclusion Criteria:

  • Any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate
  • Have any condition or procedure that has compromised neurological control of the upper airway
  • Unable to operate the patient programmer
  • Pregnant or plan to become pregnant, and breastfeeding women
  • Require magnetic resonance imaging (MRI)
  • Have an implantable device that may be susceptible to unintended interaction with the Inspire system.

Additional exclusions for study purposes only

  • Body Mass Index (BMI) of >32
  • Central + mixed apneas > 25% of the total apnea-hypopnea index (AHI)
  • Neuromuscular disease
  • Hypoglossal-nerve palsy
  • Severe restrictive or obstructive pulmonary disease
  • Moderate-to-severe pulmonary arterial hypertension
  • Severe valvular heart disease
  • New York Heart Association class III or IV heart failure
  • Recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months)
  • Persistent uncontrolled hypertension despite medication use
  • Coexisting nonrespiratory sleep disorders that would confound functional sleep assessment
  • Any chronic medical illness or condition that contraindicates a surgical procedure under general anesthesia, as judged by the clinical study Investigator
  • a terminal illness with life expectancy < 12 months
  • Active psychiatric disease (psychotic illness, major depression, or acute anxiety attacks) which prevents subject compliance with the requirements of the investigational study testing
  • Radiotherapy or ablation therapy of the head and/or neck
  • Surgical resection for cancer or congenital malformations in the larynx, tongue, or throat(with exception of tonsillectomy and/or adenoidectomy)
  • Previous surgery within 3 months performed on the soft-palate tissue
  • Obvious fixed upper airway obstructions (tumors, polyps, unilateral nasal obstruction)
  • Need for chronic supplemental oxygen therapy for any other reason, pO2 (partial pressure of oxygen) < 55 mm Hg
  • Clinical evidence of severe renal failure (Stage 4 or 5) undergoing dialysis or expected to institute dialysis within 6 months
  • Patients on medication that may alter consciousness, the pattern of respiration or sleep architecture (for example, benzodiazepiones, opiates, neuroleptics, prescription stimulants, phenothiazine, or any form of chemical substance abuse)
  • Patients taking blood thinning medications (for example warfarin, aspirin, plavix or other blood thinning agents which cannot be safety stopped or bridged temporarily to allow surgery to take place)
  • Any other reason for the investigator deems that the subject is unfit for participation in the study
  • Subject in exclusion period for another study
  • Subject under administrative or judicial control.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844295


Contacts
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Contact: Renaud RT TAMISIER, PhD 04 76 76 84 69 ext +33 RTamisier@chu-grenoble.fr
Contact: Florence FB BOURCIER 04 76 76 79 00 ext +33 FBourcier@chu-grenoble.fr

Locations
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France
UniversityHospitalGrenoble Recruiting
Grenoble, France, 38043
Contact: Renaud Tamisier, MD    +33 476768469    rtamisier@chu-grenoble.fr   
Contact: Steffy MASUCCO, MS    +33 476767167    smasucco@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
Inspire Medical Systems, Inc.
Investigators
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Principal Investigator: Renaud RT TAMISIER, PhD University Hospital, Grenoble
Publications:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03844295    
Other Study ID Numbers: 38RC18.030
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
stimulation
hypoglossal nerve
Upper-airway
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases